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We are certified
As early as January 2021, OSYPKA has already secured its Quality Management System (QMS) in accordance with the European Medical Device Regulation (MDR) QMS.
Below you will find the publicly accessible certificates.
We are permitted to state that: Osypka Medtec operates a Quality Management System which complies with the requirements of ISO13485:2016.
Additional certificates can be viewed and downloaded in the login area.
If you do not have login details, please do not hesitate to contact us and request registration.